Day

June 3, 2015
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to...
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Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1647-2015 REASON The firm was informed that while raising the patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1657-2015 REASON The firm was informed that while raising the patient couch on...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1656-2015 REASON The firm was informed that while raising the patient couch on...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1648-2015 REASON The firm was informed that while raising the...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1649-2015 REASON The firm was informed that while raising the patient couch...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1655-2015 REASON The firm was informed that while raising the patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1650-2015 REASON The firm was informed that while raising the patient couch...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1651-2015 REASON The firm was informed that while raising the patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1654-2015 REASON The firm was informed that while raising the patient...
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Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area....
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Company: Medtronic Neuromodulation Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a...
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Company: Elekta Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-1712-2015 REASON Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. RECALLING FIRM/MANUFACTURER...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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